Improving mental health and end-of-life care in residents of nursing homes: A cluster randomized clinical trial of efficacy (No:222113)

Background: Nursing home (NH) patients have complex mental and physical health problems, disabilities and social needs, compounded by widespread prescription of psychotropic drugs. To preserve their dignity and quality of life (QoL) is an important goal in our society. This can only be achieved within NHs that offer high competent conditions of treatment and care. COSMOS (COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, and Safety) is a practical intervention to improve clinical and psychiatric challenges in NH patients. The intervention combines most effective research results to improve staff competence, and patients? mental health, safety, QoL, and to reduce medication use and costs. Design: The efficacy testing of the COSMOS intervention includes a 2-month pilot study in 9 NHs, 9-month cluster randomized clinical trial (RCT), and the development of manuals and education of NH staff. Repeated theoretical and practical training credible education of nursing home managers, caregivers and physicians, information and interviews of the relatives, hot-line follow up of included NHs, and repeated feedbacks by staff are central parts of the implementation process. 380 patients, >65 years, will be recruited from 40 NHs in Askøy, Sund, Oygarden, Bergen, Stavanger, Bærum, and Sarpsborg. NHs will be randomized to either COSMOS or current best practice. Outcome measures: CMAI, QUALID, QUALIDEM, EQ-5D and cost-utility analysis (RUD-FOCA); NPI-NH; ADL; Cornell; MOBID-2; psychotropic drug use; drug-related problems; pain and symptom management; hospital admission, and mortality. To investigate sleep problems and circadian misalignment Actigraph assessments will be used. Discussion: It is the primary aim of COSMOS to implement and test an effective and logical intervention to improve the quality of life and mental health of, and optimize treatment conditions and communication with patients living in Norwegian NHs.